- FDA says it has ‘several outstanding issues’ with Heplisav-B
- Another panel will be scheduled as needed, agency says
Dynavax Technologies Corp. fell as much as 36 percent Friday after the U.S. Food and Drug Administration canceled a meeting of outside experts who were going to assess the drugmaker’s vaccine for the hepatitis B virus.
The FDA said it canceled the panel, originally scheduled for Nov. 16, to give it time to “review and resolve several outstanding issues.” The FDA said in a statement that it will schedule another meeting as needed and plans to continue internally evaluating the vaccine, called Heplisav-B.
Dynavax shares were down 26 percent to $11.79 at 3:07 p.m. in New York, after falling as low as $10.14 -- the biggest intraday loss since June 2013. The Berkeley, California-based company didn’t immediately respond to questions about the FDA’s issues with the drug.
Advisory panels bring together outside experts, typically doctors and academics, to discuss an experimental drug or new use for an approved drug. The panels often vote on whether the FDA should approve the drug, though the agency doesn’t have to follow their recommendation. A cancellation of the panel can delay the agency’s decision on the drug.